A randomized trial of topical cyclosporin 0.05% in topical steroid–resistant atopic keratoconjunctivitis

doi:10.1016/j.ophtha.2003.05.035

Ophthalmology

Volume 111, Issue 3, March 2004, Pages 476-482

https://doi.org/10.1016/j.ophtha.2003.05.035 Get rights and content

Abstract

Objective

To evaluate the short-term efficacy and safety of topical cyclosporin A 0.05% in the treatment of patients with severe, steroid-resistant atopic keratoconjunctivitis (AKC).

Design

Multicenter, placebo-controlled, double-masked, randomized trial.

Participants

Twenty-two patients with AKC refractory to topical steroid treatment.

Intervention

Patients were randomly assigned (1:1) to treatment with topical 0.05% cyclosporin A eyedrops or a placebo (artificial tears) for a period of 28 days, 6 times daily during the first 2 weeks and 4 times daily during the last 2 weeks.

Main outcome measures

Symptoms (itching, tearing, discomfort, mucous discharge, and photophobia) and signs (bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) of AKC recorded on the day of enrollment and at the end of the treatment period.

Results

A composite score computed by summing the severity grade over all 5 symptoms and 6 signs of AKC for each patient indicated a greater improvement in the cyclosporin A group relative to the placebo at the end of the 4-week treatment period (P = 0.048 and P = 0.002, for symptoms and signs, respectively). No adverse effects of the treatment with cyclosporin A 0.05% eyedrops were observed.

Conclusions

Topical cyclosporin A 0.05% seems to be safe and have some effect in alleviating signs and symptoms of severe AKC refractory to topical steroid treatment.

Section snippets

Patients

This study was conducted at 3 centers: The Wilmer Eye Institute, Baltimore, Maryland (14 patients); Moorfields Eye Hospital, London, United Kingdom (6 patients); and Bascom Palmer Eye Institute, Miami, Florida (2 patients). The study protocol was approved by the institutional review board at each site. Adult patients with a diagnosis of AKC who were willing to comply with the protocol and who provided informed consent were enrolled in the study. All patients were known to have had a

Results

Twenty-two patients met the criteria for inclusion in this clinical trial. The distribution of baseline characteristics in the combined sample, and according to assigned treatment, is shown in Table 2. Overall, 40.9% were female, and the mean patient age was 42.6 years (range, 22–73). There was no statistically significant difference between the 2 groups in terms of gender or mean age. There was no statistically significant difference in the severity of symptoms and signs at the enrollment

Discussion

The results of our trial suggest that topical cyclosporin A is of benefit in the treatment of patients with topical corticosteroid–resistant AKC. Although limited by a small sample size and relatively short duration, these results indicate that improvement in the symptoms and signs of AKC was consistently greater in those assigned to treatment with cyclosporin A 0.05% than in those in the placebo group. Another weakness of the study is the use of artificial tears rather than the actual vehicle,

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Manuscript no. 220822.

Supported, in part, by an unrestricted research grant from Allergan Inc. Dr Schein is supported in part by a National Institutes of Health grant (no. K24EY00395) and the Burton Grossman Fund for Preventive Ophthalmology.

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Original articleA randomized trial of topical cyclosporin 0.05% in topical steroid–resistant atopic keratoconjunctivitis☆

Abstract

Objective

Design

Participants

Intervention

Main outcome measures

Results

Conclusions

Section snippets

Patients

Results

Discussion

Ophthalmology

J Allergy Clin Immunol

Ophthalmology

Ophthalmology

Surv Ophthalmol

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

Topical cyclosporine inhibits mast cell-mediated conjunctivitis

Invest Ophthalmol Vis Sci

Original article
A randomized trial of topical cyclosporin 0.05% in topical steroid–resistant atopic keratoconjunctivitis☆